FDA: Page 20
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GE HealthCare cuts formaldehyde levels in neonatal incubators with revised process
The FDA previously alerted healthcare providers to the potential for neonatal incubators to emit airborne chemicals.
By Nick Paul Taylor • Oct. 17, 2023 -
Elise Reuter/MedTech Dive
FDA: ‘We have had a very loud voice’ on EtO
The agency said it is working closely with the Environmental Protection Agency, which is slated to implement a final rule in March limiting ethylene oxide emissions for medical device sterilizers.
By Elise Reuter • Oct. 16, 2023 -
Explore the Trendline➔
Permission granted by Boston Scientific
TrendlineNew medical devices are reshaping the medtech industry
From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.
By MedTech Dive staff -
Courtesy of BusinessWire/Masimo
Masimo wins de novo authorization for measure of high blood oxygen levels
The ORi device is intended to support standard pulse oximetry by providing additional insights into patients with higher than normal oxygenation.
By Nick Paul Taylor • Oct. 16, 2023 -
Mario Tama via Getty Images
J&J receives 510(k) clearance for foot fixation device, targets growing bunion market
The clearance comes shortly after Stryker introduced a minimally invasive system for treating bunions.
By Nick Paul Taylor • Oct. 16, 2023 -
Courtesy of Grail
Illumina details EC timeline, funding requirements for Grail divestment
The European Commission ordered the gene sequencing company to support Grail with two-and-a-half years of funding if it pursues a spinoff.
By Susan Kelly • Oct. 13, 2023 -
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FDA prioritizes guidance on AI, cybersecurity, pulse oximeters in stacked schedule for 2024
The administration is ramping up production of medtech guidance, adding 18 draft documents to the list of priorities for the upcoming financial year.
By Nick Paul Taylor • Oct. 13, 2023 -
European Commission orders Illumina to divest Grail
The order includes an undisclosed timeline and potential additional fines. Illumina, which has been anticipating the decision, maintains the commission does not have jurisdiction over the completed merger.
By Susan Kelly • Oct. 12, 2023 -
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Boston Scientific wins diabetic neuropathy approval, joining rivals in growing market
The expanded indication positions Boston Scientific to challenge Abbott, Medtronic and Nevro for the emerging opportunity in spinal cord stimulation to treat the condition.
By Nick Paul Taylor • Oct. 12, 2023 -
Elise Reuter/MedTech Dive
FDA to establish digital health advisory committee
The agency is seeking advisers to help it understand the benefits, risks and outcomes associated with digital technologies.
By Elise Reuter • Oct. 12, 2023 -
Courtesy of Abiomed/J&J
J&J’s Abiomed hit with FDA warning letter over Impella heart pump
The letter identifies quality system problems in a group of recalled devices and says monitoring software used with the pump requires premarket authorization.
By Susan Kelly • Oct. 12, 2023 -
AdvaMed elevates digital health center to division, names board
The new division will focus on four core policy priorities under Chair Taha Kass-Hout, chief technology officer at GE HealthCare.
By Susan Kelly • Oct. 10, 2023 -
Courtesy of HistoSonics
J&J-backed HistoSonics gets de novo clearance for liver cancer treatment
The system offers a minimally invasive alternative to surgical resection and thermal ablation in patients with primary and metastatic liver cancers.
By Nick Paul Taylor • Oct. 10, 2023 -
Courtesy of Grail
EU poised to mandate Illumina sell Grail liquid biopsy unit: FT
Regulators could order the divestment of the business as soon as next week to punish Illumina for defying their authority and “illegally” acquiring Grail.
By Nick Paul Taylor • Oct. 10, 2023 -
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Invitae test for hereditary cancers gains FDA de novo nod
The test analyzes DNA from a single blood sample to identify hundreds of variants in 47 genes associated with predispositions for a range of cancer types.
By Susan Kelly • Oct. 3, 2023 -
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FDA expands total product life cycle program to cover neurological devices
The agency could enroll up to 45 additional devices over the coming year.
By Nick Paul Taylor • Oct. 3, 2023 -
Courtesy of U.S. Food and Drug Administration
FDA details switch to electronic filings for 510(k), de novo submissions
The guidance documents advance the transition to eSTAR, an electronic template the FDA is adopting to meet legislative requirements.
By Nick Paul Taylor • Oct. 3, 2023 -
Permission granted by Mayo Clinic
Mayo Clinic partner earns 510(k) clearance for heart failure screening algorithm
The algorithm analyzes 12-lead ECGs to show if a patient may be developing heart failure.
By Nick Paul Taylor • Oct. 2, 2023 -
Permission granted by Veeva Systems
FDA to regulate lab-developed tests under proposed rule
The tests have come under scrutiny by the agency and lawmakers, but the FDA is still likely to face pushback on the changes.
By Elise Reuter • Sept. 29, 2023 -
Sarah Silbiger via Getty Images
FDA posts guidance on how to simplify updates to antimicrobial resistance tests
The advice focuses on predetermined change control plans, a mechanism the regulator sees as a way to streamline updates in multiple areas.
By Nick Paul Taylor • Sept. 29, 2023 -
Samuel Corum via Getty Images
As government shutdown looms, medical device reviews expected to continue
The FDA could furlough nearly a fifth of its staff by Sunday if Congress doesn’t reach a funding agreement.
By Elise Reuter • Sept. 28, 2023 -
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FDA finalizes guidance on cybersecurity for medical devices
Congress granted the agency authority to deny premarket submissions that lack cybersecurity information, starting in October.
By Nick Paul Taylor • Sept. 27, 2023 -
Edwards Lifesciences says it was target of surprise EU antitrust inspection
The European Commission announced the action last week without naming the cardiovascular device company.
By Susan Kelly • Sept. 26, 2023 -
Sarah Silbiger via Getty Images
Intarcia’s diabetes drug-device combo voted down again by FDA panel
The 19-member advisory committee unanimously voted against Intarcia in the review, citing cardiovascular and kidney safety concerns.
By Gwendolyn Wu • Sept. 25, 2023 -
Courtesy of Medtronic
Medtronic receives CE mark for CGM sensor, boosting challenge to Abbott and Dexcom
Medtronic has made the sensor smaller and eliminated the need for fingersticks to calibrate the device, bringing a challenger to market leaders Abbott and Dexcom.
By Nick Paul Taylor • Sept. 25, 2023 -
Sarah Silbiger via Getty Images
FDA shares draft medical device harmonization plan to meet MDUFA V goal
The FDA outlined deadlines for actions it will take, including creating a mechanism for working with regulatory partners.
By Nick Paul Taylor • Sept. 25, 2023
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